Bionano Genomics (NASDAQ:BNGO) Chairman and Interim CEO Albert Luderer outlined the company’s optical genome mapping strategy, recent reimbursement developments and financial targets during the 2026 H.C. Wainwright Global Investment Conference.
Luderer said Bionano’s optical genome mapping, or OGM, technology digitizes and analyzes chromosome structures to identify copy-number variations and structural variants associated with disease. The company is focusing its commercial efforts on hematologic oncology, constitutional genetic diseases and quality-control applications for engineered cells used in therapeutic settings.
Clinical adoption and validation
Luderer said OGM is gaining clinical adoption as laboratories seek alternatives or complements to conventional cytogenetic methods, including karyotyping, fluorescent in situ hybridization, or FISH, and microarrays. He said karyotyping can be difficult and expensive, while FISH requires laboratories to select targeted probes and microarrays are primarily used for copy-number analysis.
The company’s Saphyr and Stratys systems use labeled DNA molecules that flow through nanochannels, generating images that are used to reconstruct chromosomal structures. Luderer said Bionano’s platform includes DNA isolation and labeling products, analyzers and high-performance computing infrastructure powered by NVIDIA graphics processing units.
Bionano has recorded more than 16,000 genomes analyzed using its technology, Luderer said. He added that there are thousands of clinical publications involving OGM, including approximately 450 publications counted during the prior year, with the company expecting the total to exceed that level in the current year.
Reimbursement progress
Luderer highlighted reimbursement as a key commercial catalyst. He said CPT codes for OGM-based testing in hematologic oncology and constitutional genetic diseases became effective in January. The stated laboratory-level reimbursement amounts are $1,853 for hematologic malignancies and $1,263 for genetic-disorder testing.
In late August, the company received favorable news regarding a provisional local coverage determination from MolDX for OGM-based genome-wide molecular assays used to detect copy-number alterations and structural variants in hematologic neoplasms, according to Luderer. The proposed determination remains open for public comment.
He said states shown as recognizing MolDX coverage determinations account for roughly 60% of the U.S. population. Luderer also said Bionano is working with national authorities in Europe regarding reimbursement.
Separately, Luderer said New York State approved Memorial Sloan Kettering Cancer Center’s laboratory hematology workflow for using OGM in hematologic oncology. He characterized it as the second such state approval, following an approval involving the University of Rochester.
Customer utilization and financial measures
At the end of 2025, Bionano had 221 active sites and approximately 387 active instruments, Luderer said. About 25% of customers accounted for the majority of sales, which the company identifies as routine-use customers.
Among roughly 130 major routine-use sites, laboratories with validated laboratory-developed tests generated approximately $131,000 in revenue per site, compared with about one-third of that amount at sites working on approved laboratory-developed tests, according to Luderer.
The company shifted its strategy in 2023 toward driving routine usage and flow-cell utilization rather than emphasizing instrument sales. It also discontinued its Lineagen reference-laboratory business for developmental diseases of newborns, reducing top-line sales by $7 million, while retaining CLIA-certified laboratories, Luderer said.
He said Bionano reduced non-GAAP operating expenses by approximately 71% beginning in the first quarter of 2023 and expanded gross margin by about 25 percentage points over that period. Core revenue for the posted year was $28.5 million.
For the second quarter, Bionano reported revenue of $8.2 million, up about 25% from the prior-year period, and sold a record 9,219 flow cells. Gross margin was 53%, Luderer said.
Outlook and capital needs
Looking ahead, Luderer said Bionano expects approximately 56% year-over-year growth next year, projecting revenue of $50 million to $54 million and sales of 48 to 55 new instruments. The company expects to reach break-even during the fourth quarter of next year, he said.
Its longer-term plan calls for revenue of $31 million to $33 million in the current year, followed by $50 million to $54 million next year, $70 million thereafter and more than $100 million in fiscal 2029. Flow-cell sales are expected to be the primary contributor to that growth, with projected volume rising from 39,000 to 149,000 flow cells over the planning period.
Luderer said current-year growth has been constrained by capital expenditures and production capacity. He said Bionano needs to raise additional capital to expand its production line, particularly for flow cells, and expects the business to become self-funding by 2029.
About Bionano Genomics (NASDAQ:BNGO)
Bionano Genomics, Inc (NASDAQ: BNGO) develops and commercializes high?resolution genome analysis tools designed to map structural variants and large?scale genomic rearrangements. At the core of its technology is the Saphyr® optical genome mapping system, which uses nanochannel arrays to linearize megabase?length DNA molecules, proprietary fluorescent labeling reagents to highlight specific sequence motifs, and advanced image processing software to detect structural changes with high sensitivity.
